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The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphology | Active Comparator | Embryos selected for transfer will be based on morphology alone. |
|
| GemART assay | Experimental | Embryos selected for transfer will be based upon morphology and GemART assay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphology | Other | Embryos selected for transfer will be based upon morphology alone. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Clinical pregnancy, recorded as either positive or negative, will be determined using vaginal ultrasound during post-transfer week 4-9. Clinical Pregnancy rate for embryos selected using the GemART assay in conjunction with morphology will be compared with clinical pregnancy rate for embryos selected using morphology alone. | Recorded at post-transfer week 4-9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Jarrett, MD | IVF Indiana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Institute | Oak Brook | Illinois | 60523 | United States | ||
| IVF Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23200692 | Background | Iager AE, Kocabas AM, Otu HH, Ruppel P, Langerveld A, Schnarr P, Suarez M, Jarrett JC, Conaghan J, Rosa GJ, Fernandez E, Rawlins RG, Cibelli JB, Crosby JA. Identification of a novel gene set in human cumulus cells predictive of an oocyte's pregnancy potential. Fertil Steril. 2013 Mar 1;99(3):745-752.e6. doi: 10.1016/j.fertnstert.2012.10.041. Epub 2012 Nov 29. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| GemART assay |
| Other |
Embryos selected for transfer will be based upon morphology and GemART assay. |
|
| Indianapolis |
| Indiana |
| 46280 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Reproductive Medicine Associates of Michigan | Troy | Michigan | 48084 | United States |